A validator is a device that enables users to monitor and validate the safety of their important processes and/or applications, such as pharmaceutical, biotechnology, and medical device manufacturing processes. Monitoring and validating the safety of a process and/or application is known as “qualification.” An example of a specific qualification procedure is monitoring and validating temperatures in a sterilization process in a medical device manufacturing process. Another example is monitoring and validating temperatures at various stages of a pharmaceutical manufacturing process. The purpose of qualifying a process and the equipment used in such process is to document the performance of the process and equipment, either to satisfy regulatory requirements or to perform studies of production processes and equipment.
An example of a conventional validator is the Kaye Validator, sold by Amphenol Sensor Systems and illustrated in FIG. 17A as a validator 1700. As seen in FIG. 17A, the conventional validator 1700 comprises an enclosure 1710 and an interface 1720 comprising a display unit 1730 and a plurality of inputs 1740.
Referring now to FIG. 17B, there is illustrated a rear view of the validator 1700. As seen, the validator 1700 further comprises three internal receptacles, left, center, and right receptacles (not illustrated), for receiving sensor input modules (SIMs). Two of the receptacles of the validator 1700 (the left and right receptacles) are illustrated as not being used and are, therefore, covered by respective plates 1750A and 1750C. The center receptacle is illustrated as being used, and a sensor input module (SIM) 1755B is illustrated as being disposed therein. The SIM 1755B is connected to a plurality of temperature sensors for monitoring and validating temperatures of a process being qualified.
Disposed on the rear of the enclosure 1710 of the conventional validator 1700 is a plurality of ports 1760. FIG. 17C illustrates a close-up view of a portion 17C of the rear of the enclosure 1710 of the conventional validator 1700. As shown, the validator 1700 further comprises two ports 1760A and 1760B for a resistance temperature device (RTD), such as the Kaye Intelligent RTD sold by Amphenol Sensor Systems, and a port 1760C for temperature reference. The ports 1760A through 1760C may be RJ11 ports.
The validator 1700 further comprises a port 1760D for communicating with a computer, a port 1760E for communicating with a printer, a port 1760F for communicating with an external device, and a port 1760G for communicating with a programmable logic controller (PLC). The port 1760D may be a PC serial communication port; the port 1760E may be a parallel printer port; the port 1760F may be may be a USB port; and the port 1760G may be a NO/NC relay output port.
The conventional validator 1700 uses user-configured parameters to conduct the qualification procedure. Such parameters include start and stop qualification conditions, start and stop exposure conditions, etc. During a qualification study, the conventional validator 1700 collects and logs data provided by the sensors connected to the SIMs, such as the SIM 1755B. The conventional validator 1700 also performs calculations on collected data. Calculations may include: lethality calculations, saturated steam calculations, statistical calculations, interval summary calculations, interval minimum calculations, interval maximum calculations, and interval average calculations.
The collected and calculated data, referred to as “qualification data,” may be displayed in real-time on the display unit 1730. They may also be stored in an internal memory in the conventional validator 1700 or exported to a USB storage device connected to the port 1760F. The conventional validator 1700 may generate reports based on the qualification data. It may also export the qualification data to a printer attached to the port 1760E for printing in a report.
During the qualification study, the conventional validator 1700 also displays and logs qualification events, such as the qualification study time (an elapsed time since the beginning of the study), an exposure cycle time, a qualification start event, exposure cycle start and stop events, each occurrence of all group (collection of sensors) events that have been triggered during the study, and a stop qualification event. A time stamp (date and time) for each event is displayed and logged.
After the qualification study is complete, the validator 1700 may generate a qualification report.